FOR ADULTS WITH ACTIVE PsA

DEMONSTRATED JOINT SYMPTOM CONTROL IN PsA

ACR20 response at Week 14 (primary endpoint) vs placebo*†‡:

75%

of patients receiving SIMPONI ARIA® +/- MTX (181/241) achieved ACR20 response (P<0.001)

VS

22%

of patients receiving placebo +/- MTX (52/239)1-3

ACR20 response in patients receiving SIMPONI ARIA® + MTX was similar to those receiving SIMPONI ARIA® without MTX

Rapid ACR20 response at Week 2*†‡:

46%

of patients receiving SIMPONI ARIA® +/- MTX (110/241) achieved ACR20 response (P<0.001)

VS

8%

of patients receiving placebo +/- MTX (18/239)1-3

 

ACR20 response at Week 2 was a prespecified endpoint that was not adjusted for multiplicity; P value is considered nominal.

ACR20 RESPONSE AT WEEK 24*†‡:

77%
of patients receiving SIMPONI ARIA® +/- MTX (185/241) achieved ACR20 response

VS

24%
of patients receiving placebo +/- MTX (58/239)1-3

ACR20 response at Week 2 and Week 24 were prespecified endpoints that were not adjusted for multiplicity; P values are considered nominal.

*The same patients may not have responded at each time point.

In this intention-to-treat (ITT) analysis, patients were considered to be nonresponders if they experienced any of the following: increased the dose of MTX or oral corticosteroids over baseline for PsA not as part of early escape; initiated treatment with DMARDs, systemic immunosuppressives, treatment with oral, intravenous (IV), or intramuscular (IM) corticosteroids, and/or biologics for PsA; met early escape criteria at Week 16 and started concomitant medication intervention; or discontinued treatment due to an unsatisfactory therapeutic effect.

ACR20 response is based on imputed data using treatment failure, last observation carried forward (LOCF) for partially missing data, and nonresponder imputation (NRI) for completely missing data.

Study design: GO-VIBRANT was a global, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of SIMPONI ARIA® compared with placebo in 480 adult patients with active PsA. The target study population was biologic-naïve patients with active PsA for ≥6 months who met ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria at screening. Patients in this trial had a diagnosis of PsA for at least 6 months and had symptoms of active disease (≥5 swollen joints and ≥5 tender joints and a CRP level of ≥0.6 mg/dL). At Week 0, patients were randomized in a 1:1 ratio to 1 of 2 treatment groups. Patients were allowed to be treated with or without MTX. Patients in the placebo group (n=239) were randomized to receive IV placebo infusions at Weeks 0, 4, 12, and 20. Patients in the SIMPONI ARIA® group (n=241) were randomized to receive SIMPONI ARIA® 2 mg/kg infusions at Weeks 0, 4, and q8w thereafter through Week 52. Patients were to receive a placebo infusion at Week 24 to maintain the treatment blind. At Week 24, all patients switched to treatment with SIMPONI ARIA® 2 mg/kg and were to receive administrations at Weeks 24, 28, and q8w through Week 52. The primary endpoint was the percentage of patients achieving an ACR20 response at Week 14.

ACR50 response at Week 14 vs placebo*†‡:

44%

of patients receiving SIMPONI ARIA® +/- MTX (105/241) achieved ACR50 response (P<0.001)

VS

6%

of patients receiving placebo +/- MTX (15/239)1-3

ACR50 response at Week 2*†‡:

13%

of patients receiving SIMPONI ARIA® +/- MTX (31/241) achieved ACR50 response (P<0.001)

VS

0.4%

of patients receiving placebo +/- MTX (1/239)1

ACR50 response at Week 24*†‡:

54%
of patients receiving SIMPONI ARIA® +/- MTX (130/241) achieved ACR50 response

VS

6%
of patients receiving placebo +/- MTX (14/239)1-3

ACR50 response at Week 2 was a prespecified endpoint that was not adjusted for multiplicity; P value is considered nominal.

*The same patients may not have responded at each time point.

In this intention-to-treat (ITT) analysis, patients were considered to be nonresponders if they experienced any of the following: increased the dose of MTX or oral corticosteroids over baseline for PsA not as part of early escape; initiated treatment with DMARDs, systemic immunosuppressives, treatment with oral, intravenous (IV), or intramuscular (IM) corticosteroids, and/or biologics for PsA; met early escape criteria at Week 16 and started concomitant medication intervention; or discontinued treatment due to an unsatisfactory therapeutic effect.

ACR50 response is based on imputed data using treatment failure, last observation carried forward (LOCF) for partially missing data, and nonresponder imputation (NRI) for completely missing data.

Study design: GO-VIBRANT was a global, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of SIMPONI ARIA® compared with placebo in 480 adult patients with active PsA. The target study population was biologic-naïve patients with active PsA for ≥6 months who met ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria at screening. Patients in this trial had a diagnosis of PsA for at least 6 months and had symptoms of active disease (≥5 swollen joints and ≥5 tender joints and a CRP level of ≥0.6 mg/dL). At Week 0, patients were randomized in a 1:1 ratio to 1 of 2 treatment groups. Patients were allowed to be treated with or without MTX. Patients in the placebo group (n=239) were randomized to receive IV placebo infusions at Weeks 0, 4, 12, and 20. Patients in the SIMPONI ARIA® group (n=241) were randomized to receive SIMPONI ARIA® 2 mg/kg infusions at Weeks 0, 4, and q8w thereafter through Week 52. Patients were to receive a placebo infusion at Week 24 to maintain the treatment blind. At Week 24, all patients switched to treatment with SIMPONI ARIA® 2 mg/kg and were to receive administrations at Weeks 24, 28, and q8w through Week 52. The primary endpoint was the percentage of patients achieving an ACR20 response at Week 14.

ACR70 response at Week 14 vs placebo*†‡:

25%

of patients receiving SIMPONI ARIA® +/- MTX (59/241) achieved ACR70 response (P<0.001)

VS

2%

of patients receiving placebo +/- MTX (5/239)1-3

ACR70 response at Week 24*:

33%
of patients receiving SIMPONI ARIA® +/- MTX (79/241) achieved ACR70 response (P<0.001)

VS

3%
of patients receiving placebo +/- MTX (8/239)1-3

ACR70 response at Week 2 and Week 24 were prespecified endpoints that were not adjusted for multiplicity; P values are considered nominal.

*The same patients may not have responded at each time point.

In this intention-to-treat (ITT) analysis, patients were considered to be nonresponders if they experienced any of the following: increased the dose of MTX or oral corticosteroids over baseline for PsA not as part of early escape; initiated treatment with DMARDs, systemic immunosuppressives, treatment with oral, intravenous (IV), or intramuscular (IM) corticosteroids, and/or biologics for PsA; met early escape criteria at Week 16 and started concomitant medication intervention; or discontinued treatment due to an unsatisfactory therapeutic effect.

ACR70 response is based on imputed data using treatment failure, last observation carried forward (LOCF) for partially missing data, and nonresponder imputation (NRI) for completely missing data.

Study design: GO-VIBRANT was a global, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of SIMPONI ARIA® compared with placebo in 480 adult patients with active PsA. The target study population was biologic-naïve patients with active PsA for ≥6 months who met ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria at screening. Patients in this trial had a diagnosis of PsA for at least 6 months and had symptoms of active disease (≥5 swollen joints and ≥5 tender joints and a CRP level of ≥0.6 mg/dL). At Week 0, patients were randomized in a 1:1 ratio to 1 of 2 treatment groups. Patients were allowed to be treated with or without MTX. Patients in the placebo group (n=239) were randomized to receive IV placebo infusions at Weeks 0, 4, 12, and 20. Patients in the SIMPONI ARIA® group (n=241) were randomized to receive SIMPONI ARIA® 2 mg/kg infusions at Weeks 0, 4, and q8w thereafter through Week 52. Patients were to receive a placebo infusion at Week 24 to maintain the treatment blind. At Week 24, all patients switched to treatment with SIMPONI ARIA® 2 mg/kg and were to receive administrations at Weeks 24, 28, and q8w through Week 52. The primary endpoint was the percentage of patients achieving an ACR20 response at Week 14.